BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILTEX CHP LUMERA GEL, 485CC

    MDR report key: 8335755 · Received February 13, 2019

    Report

    Report Number
    1645337-2019-08526
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 21, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: LEFT- MENTOR SILTEX CHP LUMERA GEL, 485CC SILICONE BREAST IMPLANT, CATALOG NUMBER 3241351, SERIAL NUMBER (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX CHP LUMERA GEL, 485CC SILICONE BREAST IMPLANTS WHICH THE RIGHT SIDE RUPTURED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY MRI EXAMINATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130643 SILTEX CHP LUMERA GEL, 485CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5608145

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other